October 2025
May help eligible patients access LIBTAYO and navigate the health insurance process. LIBTAYO Surround provides resources, support, and a dedicated team to help patients throughout their treatment journey.
For any questions or concerns, or to report side effects with a Regeneron product for patients enrolled in LIBTAYO Surround, please contact LIBTAYO Surround at 1.877.LIBTAYO (1.877.542.8296) Option 1, Monday–Friday, 8 AM–8 PM Eastern time.
Indications and Usage
LIBTAYO in combination with platinum-based chemotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic.
LIBTAYO as a single agent is indicated for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic.
LIBTAYO is indicated for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
LIBTAYO is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.
LIBTAYO is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
Important Safety Information
Warnings and Precautions
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue at any time after starting treatment. While immune-mediated adverse reactions usually occur during treatment, they can also occur after discontinuation. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Early identification and management are essential to ensuring safe use of PD-1/PD-L1–blocking antibodies. The definition of immune-mediated adverse reactions included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue LIBTAYO depending on severity of the adverse reaction (see Section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if LIBTAYO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroids. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.
The incidence and severity of immune-mediated adverse reactions were similar when LIBTAYO was administered as a single agent or in combination with chemotherapy.
Immune-mediated pneumonitis: LIBTAYO can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 2.6% (33/1281) of patients receiving LIBTAYO, including Grade 4 (0.3%), Grade 3 (0.6%), and Grade 2 (1.6%). Pneumonitis led to permanent discontinuation in 1.3% of patients and withholding of LIBTAYO in 1.4% of patients. Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 61% of the 33 patients. Of the 18 patients in whom LIBTAYO was withheld, 10 reinitiated after symptom improvement; of these, 4/10 (40%) had recurrence of pneumonitis.
Immune-mediated colitis: LIBTAYO can cause immune-mediated colitis. The primary component of immune-mediated colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory immune-mediated colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 2% (25/1281) of patients receiving LIBTAYO, including Grade 3 (0.8%) and Grade 2 (0.9%). Colitis led to permanent discontinuation in 0.4% of patients and withholding of LIBTAYO in 1.2% of patients. Systemic corticosteroids were required in all patients with colitis. Colitis resolved in 56% of the 25 patients. Of the 16 patients in whom LIBTAYO was withheld, 6 reinitiated LIBTAYO after symptom improvement; of these, 4/6 (67%) had recurrence.
Immune-mediated hepatitis: LIBTAYO can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 2.4% (31/1281) of patients receiving LIBTAYO, including fatal (<0.1%), Grade 4 (0.3%), Grade 3 (1.6%), and Grade 2 (0.2%). Hepatitis led to permanent discontinuation of LIBTAYO in 1.4% of patients and withholding of LIBTAYO in 0.7% of patients. Systemic corticosteroids were required in all patients with hepatitis. Additional immunosuppression with mycophenolate was required in 13% (4/31) of these patients. Hepatitis resolved in 39% of the 31 patients. Of the 9 patients in whom LIBTAYO was withheld, 5 reinitiated LIBTAYO after symptom improvement; of these, 1/5 (20%) had recurrence.
Immune-mediated endocrinopathies:
Immune-mediated nephritis with renal dysfunction: LIBTAYO can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.7% (9/1281) of patients receiving LIBTAYO, including fatal (<0.1%), Grade 3 (<0.1%), and Grade 2 (0.5%). Nephritis led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 0.4% of patients. Systemic corticosteroids were required in all patients with nephritis. Nephritis resolved in 78% of the 9 patients. Of the 5 patients in whom LIBTAYO was withheld, 4 reinitiated LIBTAYO after symptom improvement; of these, 1/4 (25%) had recurrence.
Immune-mediated dermatologic adverse reactions: LIBTAYO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1–blocking antibodies. Immune-mediated dermatologic adverse reactions occurred in 1.9% (24/1281) of patients receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (0.8%). Immune-mediated dermatologic adverse reactions led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions resolved in 71% of the 24 patients. Of the 17 patients in whom LIBTAYO was withheld for dermatologic adverse reaction, 13 reinitiated LIBTAYO after symptom improvement; of these, 5/13 (38%) had recurrence of the dermatologic adverse reaction. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
Other immune-mediated adverse reactions: The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 1281 patients who received LIBTAYO or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.
Severe or life-threatening infusion-related reactions occurred in 0.2% of patients receiving LIBTAYO as a single agent. Monitor patients for signs and symptoms of infusion-related reactions. Common symptoms of infusion-related reaction include nausea, pyrexia, and vomiting. Interrupt or slow the rate of infusion or permanently discontinue LIBTAYO based on severity of reaction.
Complications of Allogeneic HSCT
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1–blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
LIBTAYO can cause fetal harm when administered to a pregnant woman due to an increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose.
Adverse Reactions
The most common adverse reactions (≥15%) are:
Please click here for full Prescribing Information.
For product information about LIBTAYO, click here. For patient support resources, visit LIBTAYO Surround.
Thank you,
For Colorado Prescribers – Click Here for Pricing Information
For Connecticut Prescribers – Click Here for Pricing Information
If you no longer wish to receive LIBTAYO emails, please reply to this message with "Unsubscribe" in the subject line.
Reference: LIBTAYO (cemiplimab-rwlc) injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc.
If you have a question about a Regeneron product, please call 1-844-643-7346.
© 2025 Regeneron Pharmaceuticals, Inc. All rights reserved.
777 Old Saw Mill River Rd, Tarrytown, NY 10591
US.LIB.25.05.0013 10/25
May help eligible patients access LIBTAYO and navigate the health insurance process. LIBTAYO Surround provides resources, support, and a dedicated team to help patients throughout their treatment journey.
For any questions or concerns, or to report side effects with a Regeneron product for patients enrolled in LIBTAYO Surround, please contact LIBTAYO Surround at 1.877.LIBTAYO (1.877.542.8296) Option 1, Monday–Friday, 8 AM–8 PM Eastern time.
May help eligible patients access LIBTAYO and navigate the health insurance process. LIBTAYO Surround provides resources, support, and a dedicated team to help patients throughout their treatment journey.
For any questions or concerns, or to report side effects with a Regeneron product for patients enrolled in LIBTAYO Surround, please contact LIBTAYO Surround at 1.877.LIBTAYO (1.877.542.8296) Option 1, Monday–Friday, 8 AM–8 PM Eastern time.
Indications and Usage
LIBTAYO in combination with platinum-based chemotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic.
LIBTAYO as a single agent is indicated for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic.
LIBTAYO is indicated for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
LIBTAYO is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.
LIBTAYO is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
Important Safety Information
Warnings and Precautions
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue at any time after starting treatment. While immune-mediated adverse reactions usually occur during treatment, they can also occur after discontinuation. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Early identification and management are essential to ensuring safe use of PD-1/PD-L1–blocking antibodies. The definition of immune-mediated adverse reactions included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue LIBTAYO depending on severity of the adverse reaction (see Section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if LIBTAYO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroids. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.
The incidence and severity of immune-mediated adverse reactions were similar when LIBTAYO was administered as a single agent or in combination with chemotherapy.
Immune-mediated pneumonitis: LIBTAYO can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 2.6% (33/1281) of patients receiving LIBTAYO, including Grade 4 (0.3%), Grade 3 (0.6%), and Grade 2 (1.6%). Pneumonitis led to permanent discontinuation in 1.3% of patients and withholding of LIBTAYO in 1.4% of patients. Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 61% of the 33 patients. Of the 18 patients in whom LIBTAYO was withheld, 10 reinitiated after symptom improvement; of these, 4/10 (40%) had recurrence of pneumonitis.
Immune-mediated colitis: LIBTAYO can cause immune-mediated colitis. The primary component of immune-mediated colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory immune-mediated colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 2% (25/1281) of patients receiving LIBTAYO, including Grade 3 (0.8%) and Grade 2 (0.9%). Colitis led to permanent discontinuation in 0.4% of patients and withholding of LIBTAYO in 1.2% of patients. Systemic corticosteroids were required in all patients with colitis. Colitis resolved in 56% of the 25 patients. Of the 16 patients in whom LIBTAYO was withheld, 6 reinitiated LIBTAYO after symptom improvement; of these, 4/6 (67%) had recurrence.
Immune-mediated hepatitis: LIBTAYO can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 2.4% (31/1281) of patients receiving LIBTAYO, including fatal (<0.1%), Grade 4 (0.3%), Grade 3 (1.6%), and Grade 2 (0.2%). Hepatitis led to permanent discontinuation of LIBTAYO in 1.4% of patients and withholding of LIBTAYO in 0.7% of patients. Systemic corticosteroids were required in all patients with hepatitis. Additional immunosuppression with mycophenolate was required in 13% (4/31) of these patients. Hepatitis resolved in 39% of the 31 patients. Of the 9 patients in whom LIBTAYO was withheld, 5 reinitiated LIBTAYO after symptom improvement; of these, 1/5 (20%) had recurrence.
Immune-mediated endocrinopathies:
- Adrenal insufficiency: LIBTAYO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold LIBTAYO depending on severity. Adrenal insufficiency occurred in 0.5% (6/1281) of patients receiving LIBTAYO, including Grade 3 (0.5%). Adrenal insufficiency led to permanent discontinuation of LIBTAYO in 1 (<0.1%) patient. LIBTAYO was withheld in 1 (<0.1%) patient due to adrenal insufficiency and not reinitiated. Systemic corticosteroids were required in 83% (5/6) patients with adrenal insufficiency; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency had resolved in 17% of the 6 patients
- Hypophysitis: LIBTAYO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue depending on severity. Hypophysitis occurred in 0.5% (7/1281) of patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.3%) adverse reactions. Hypophysitis led to permanent discontinuation of LIBTAYO in 1 (<0.1%) patient and withholding of LIBTAYO in 2 (0.2%) patients. Systemic corticosteroids were required in 86% (6/7) of patients with hypophysitis. Hypophysitis resolved in 14% of the 7 patients. Of the 2 patients in whom LIBTAYO was withheld for hypophysitis, none of the patients reinitiated
- Thyroid disorders: LIBTAYO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management as clinically indicated. Withhold or permanently discontinue LIBTAYO depending on severity
- Thyroiditis: Thyroiditis occurred in 0.6% (8/1281) of patients receiving LIBTAYO, including Grade 2 (0.3%) adverse reactions. No patient discontinued LIBTAYO due to thyroiditis. Thyroiditis led to withholding of LIBTAYO in 1 (<0.1%) patient. Systemic corticosteroids were not required in any patient with thyroiditis. Thyroiditis resolved in 13% of the 8 patients. Blood thyroid stimulating hormone increased and blood thyroid stimulating hormone decreased have also been reported
- Hyperthyroidism: Hyperthyroidism occurred in 3% (39/1281) of patients receiving LIBTAYO, including Grade 3 (<0.1%) and Grade 2 (0.9%). No patient discontinued treatment and LIBTAYO was withheld in 7 (0.5%) patients due to hyperthyroidism. Systemic corticosteroids were required in 8% (3/39) of patients. Hyperthyroidism resolved in 56% of 39 patients. Of the 7 patients in whom LIBTAYO was withheld for hyperthyroidism, 2 patients reinitiated LIBTAYO after symptom improvement; of these, none had recurrence of hyperthyroidism
- Hypothyroidism: Hypothyroidism occurred in 7% (87/1281) of patients receiving LIBTAYO, including Grade 3 (<0.1%) and Grade 2 (6%). Hypothyroidism led to permanent discontinuation of LIBTAYO in 3 (0.2%) patients. Hypothyroidism led to withholding of LIBTAYO in 9 (0.7%) patients. Systemic corticosteroids were required in 1.1% (1/87) of patients with hypothyroidism. Hypothyroidism resolved in 6% of the 87 patients. Majority of the patients with hypothyroidism required long-term thyroid hormone replacement. Of the 9 patients in whom LIBTAYO was withheld for hypothyroidism, 1 reinitiated LIBTAYO after symptom improvement and did not have recurrence of hypothyroidism
- Type 1 diabetes mellitus, which can present with diabetic ketoacidosis: Monitor for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold LIBTAYO depending on severity. Type 1 diabetes mellitus occurred in <0.1% (1/1281) of patients (Grade 4). No patient discontinued treatment due to Type 1 diabetes mellitus. Type 1 diabetes mellitus led to withholding of LIBTAYO in 0.1% of patients, treatment was reinitiated after symptom improvement. Patient received long-term insulin therapy
Immune-mediated nephritis with renal dysfunction: LIBTAYO can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.7% (9/1281) of patients receiving LIBTAYO, including fatal (<0.1%), Grade 3 (<0.1%), and Grade 2 (0.5%). Nephritis led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 0.4% of patients. Systemic corticosteroids were required in all patients with nephritis. Nephritis resolved in 78% of the 9 patients. Of the 5 patients in whom LIBTAYO was withheld, 4 reinitiated LIBTAYO after symptom improvement; of these, 1/4 (25%) had recurrence.
Immune-mediated dermatologic adverse reactions: LIBTAYO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1–blocking antibodies. Immune-mediated dermatologic adverse reactions occurred in 1.9% (24/1281) of patients receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (0.8%). Immune-mediated dermatologic adverse reactions led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions resolved in 71% of the 24 patients. Of the 17 patients in whom LIBTAYO was withheld for dermatologic adverse reaction, 13 reinitiated LIBTAYO after symptom improvement; of these, 5/13 (38%) had recurrence of the dermatologic adverse reaction. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
Other immune-mediated adverse reactions: The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 1281 patients who received LIBTAYO or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.
- Cardiac/vascular: Myocarditis, pericarditis, and vasculitis. Permanently discontinue for Grades 2, 3, or 4 myocarditis
- Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, and autoimmune neuropathy
- Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss
- Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis, stomatitis
- Musculoskeletal and connective tissue: Myositis/polymyositis/dermatomyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
- Endocrine: Hypoparathyroidism
- Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection
Severe or life-threatening infusion-related reactions occurred in 0.2% of patients receiving LIBTAYO as a single agent. Monitor patients for signs and symptoms of infusion-related reactions. Common symptoms of infusion-related reaction include nausea, pyrexia, and vomiting. Interrupt or slow the rate of infusion or permanently discontinue LIBTAYO based on severity of reaction.
Complications of Allogeneic HSCT
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1–blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
LIBTAYO can cause fetal harm when administered to a pregnant woman due to an increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose.
Adverse Reactions
The most common adverse reactions (≥15%) are:
- As a single agent in mCSCC or laCSCC, mBCC or laBCC, and NSCLC with high PD-L1 expression: fatigue, musculoskeletal pain, rash, diarrhea, and anemia
- As a single agent in adjuvant CSCC at high risk of recurrence: rash and pruritus
- In combination with platinum-based chemotherapy in NSCLC: alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite
- Lactation: Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO
- Females and males of reproductive potential: Verify pregnancy status in females of reproductive potential prior to initiating LIBTAYO
Please click here for full Prescribing Information.
For product information about LIBTAYO, click here. For patient support resources, visit LIBTAYO Surround.
Thank you,
For Colorado Prescribers – Click Here for Pricing Information
For Connecticut Prescribers – Click Here for Pricing Information
If you no longer wish to receive LIBTAYO emails, please reply to this message with "Unsubscribe" in the subject line.
Reference: LIBTAYO (cemiplimab-rwlc) injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc.
If you have a question about a Regeneron product, please call 1-844-643-7346.
© 2025 Regeneron Pharmaceuticals, Inc. All rights reserved.
777 Old Saw Mill River Rd, Tarrytown, NY 10591
US.LIB.25.05.0013 10/25
May help eligible patients access LIBTAYO and navigate the health insurance process. LIBTAYO Surround provides resources, support, and a dedicated team to help patients throughout their treatment journey.
For any questions or concerns, or to report side effects with a Regeneron product for patients enrolled in LIBTAYO Surround, please contact LIBTAYO Surround at 1.877.LIBTAYO (1.877.542.8296) Option 1, Monday–Friday, 8 AM–8 PM Eastern time.
JULY 2025
LYNOZYFIC™ (linvoseltamab-gcpt) is now approved!
LYNOZYFIC is now approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.
This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME
· Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Initiate treatment with LYNOZYFIC step-up dosing to reduce the risk of CRS. Manage CRS, withhold LYNOZYFIC until CRS resolves, and modify the next dose or permanently discontinue based on severity.
· Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS during treatment. Manage neurologic toxicity, including ICANS, withhold LYNOZYFIC until neurologic toxicity, including ICANS resolves, and modify the next dose or permanently discontinue based on severity.
· Because of the risk of CRS and neurologic toxicity, including ICANS, LYNOZYFIC is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LYNOZYFIC REMS.
Please see additional Important Safety Information below.
NDC for LYNOZYFIC
Please ensure that policies and systems are updated to reflect LYNOZYFIC.
LYNOZYFIC dose (mg/mL)
Vial cap color
NDC
5 mg/2.5 mL
White
61755005401
200 mg/10 mL
Blue
61755005601
NDC=National Drug Code.
Note: The product’s NDC has been “zero-filled” to ensure creation of an 11-digit code that meets general billing standards. The zero-fill location is indicated in bold above.
HCPCS Information
Not otherwise classified, antineoplastic
J9999
Unclassified drug
J3490
Unclassified biologic
J3590
Unclassified drug or biologic (limited to ASC or HOPD claims for Medicare beneficiaries)
C9399
ASC=ambulatory surgical center; HCPCS=Healthcare Common Procedure Coding System; HOPD=hospital outpatient department.
Note: When using a temporary miscellaneous J-code, it is appropriate to indicate “1” billing unit on the claim form.
Relevant ICD-10-CM Diagnosis Codes for Relapsed/Refractory Multiple Myeloma (R/R MM)
ICD-10-CM Code
ICD-10-CM Code description
C90.00
Multiple myeloma not having achieved remission
C90.02
Multiple myeloma in relapse
C90.20
Extramedullary plasmacytoma not having achieved remission
C90.22
Extramedullary plasmacytoma in relapse
C90.30
Solitary plasmacytoma not having achieved remission
C90.32
Solitary plasmacytoma in relapse
ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification.
ICD-10-CM Diagnosis Codes for R/R MM After At Least 4 Lines of Therapy
ICD-10-CM Code
ICD-10-CM Code description
Z92.22
Personal history of monoclonal drug therapy
Z92.25
Personal history of immunosuppression therapy
LYNOZYFIC is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called LYNOZYFIC REMS. Visit LYNOZYFICREMS.com to learn more.
LYNOZYFIC Surround™ helps eligible patients access LYNOZYFIC and navigate the insurance process. Enrollment is the first step to accessing support for benefits investigation, prior authorizations, claims, and appeals.
For more information or support, please reach out to your Oncology Reimbursement Manager, call 1.844.RGN.HEME (1.844.746.4363), Option 1, Monday–Friday, 8 am–8 pm Eastern time, or visit LYNOZYFIChcp.com.
This material is provided for informational purposes only, is subject to change, and should not be construed as legal or medical advice. This information may not apply to all patients or to all health plans. Providers should exercise independent clinical judgment when selecting codes and submitting claims to accurately reflect the services and products furnished to the specific patient.
Please contact me if you’d like additional information or if you have questions regarding the attached acquisition guide.
IMPORTANT SAFETY INFORMATION (cont’d)
Warnings and Precautions
Cytokine Release Syndrome (CRS): LYNOZYFIC can cause CRS, which can be serious or life-threatening. In LINKER-MM1, CRS occurred in 46% (54/117) of patients who received LYNOZYFIC at the recommended dose, with Grade 1 CRS occurring in 35% (41/117) of patients, Grade 2 in 10% (12/117), and Grade 3 in 0.9% (1/117). Thirty-eight percent (45/117) of patients had CRS following step-up dose 1, including 1 patient who experienced Grade 3 CRS; 8% (9/117) had an initial CRS event following a subsequent dose. Seventeen percent (19/113) of patients developed CRS after step-up dose 2, 10% (11/111) developed CRS after the first full 200-mg dose of LYNOZYFIC, and 3.6% (4/110) developed CRS after the second full dose. Recurrent CRS occurred in 20% (23/117) of patients. The median time to onset of CRS from the end of infusion was 11 (range: -1 to 184) hours after the most recent dose, with a median duration of 15 (range: 1 to 76) hours.
Clinical signs and symptoms of CRS included, but were not limited to pyrexia, chills, hypoxia, tachycardia, and hypotension. Administer pretreatment medications and initiate therapy according to LYNOZYFIC step-up dosing to reduce the incidence and severity of CRS. Monitor patients for signs and symptoms of CRS after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur.
At the first sign of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines, and administer supportive care; withhold LYNOZYFIC until CRS resolves and modify the next dose or permanently discontinue LYNOZYFIC based on severity.
Infusion Related Reactions
Infusion‑related reactions (IRR) may be clinically indistinguishable from manifestations of CRS. In the patients who were treated with the recommended step-up dosing regimen and pretreatment medications, the rate of IRR was 9% [11/117 including Grade 2 IRR (4.3%) and Grade 3 IRR (1.7%)]. For IRR, interrupt or slow the rate of infusion or permanently discontinue LYNOZYFIC based on severity of reaction.
Neurologic Toxicity, including Immune Effector Cell Associated Neurotoxicity Syndrome: LYNOZYFIC can cause serious or life‑threatening neurologic toxicity, including ICANS. In LINKER-MM1, neurologic toxicity occurred in 54% of patients, with Grade 3 or 4 neurologic toxicity occurring in 8%, at the recommended dose. Neurologic toxicities included ICANS, depressed level of consciousness, encephalopathy, and toxic encephalopathy. ICANS occurred in 8% of patients who received LYNOZYFIC with the recommended dosing regimen, including Grade 3 events in 2.6%. Most patients experienced ICANS following step-up dose 1 (5%). Two patients (1.8%) experienced initial ICANS following step-up dose 2 and one patient developed the first occurrence of ICANS following a subsequent full dose of LYNOZYFIC. Recurrent ICANS occurred in one patient. The median time to onset of ICANS was 1 (range: 1 to 4) day after the most recent dose with a median duration of 2 (range: 1 to 11) days. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.
The most common clinical signs and symptoms of ICANS are confusion, depressed level of consciousness, and lethargy. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient; provide supportive therapy and consider further management per current practice guidelines. Withhold LYNOZYFIC until ICANS resolves and modify the next dose or permanently discontinue LYNOZYFIC based on severity. Counsel patients to seek immediate medical attention should signs or symptoms of neurologic toxicity, including ICANS occur at any time.
Due to the potential for neurologic toxicity, including ICANS, patients receiving LYNOZYFIC are at risk of confusion and depressed consciousness. Advise patients to refrain from driving, or operating heavy or potentially dangerous machinery, for 48 hours after completion of each of the step-up doses and in the event of new onset of any neurological symptoms, until symptoms resolve.
LYNOZYFIC REMS: LYNOZYFIC is available only through a restricted program under a REMS called the LYNOZYFIC REMS because of the risks of CRS and neurologic toxicity, including ICANS.
Infections: LYNOZYFIC can cause serious, life‑threatening, or fatal infections. In patients who received LYNOZYFIC at the recommended dose in LINKER-MM1, serious infections, including opportunistic infections, occurred in 42% of patients, with Grade 3 or 4 infections in 38% and fatal infections in 4%. The most common serious infection reported (≥10%) were pneumonia and sepsis. Two cases of progressive multifocal leukoencephalopathy (PML) occurred in patients receiving LYNOZYFIC.
Monitor patients for signs and symptoms of infection and immunoglobulin levels prior to and during treatment with LYNOZYFIC and treat appropriately. Administer prophylactic antimicrobials, antibiotics, antifungals, antivirals, vaccines, and subcutaneous or intravenous immunoglobulin (IVIG) according to guidelines, including prophylaxis for PJP and herpesviruses. Withhold LYNOZYFIC or consider permanent discontinuation of LYNOZYFIC based on severity of the infection.
Neutropenia: LYNOZYFIC can cause neutropenia and febrile neutropenia. In patients who received LYNOZYFIC at the recommended dose in LINKER-MM1, decreased neutrophil count occurred in 62% of patients with Grade 3 or 4 decreased neutrophil count in 47%. Febrile neutropenia occurred in 8% of patients.
Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local guidelines. Monitor patients with neutropenia for signs of infection. Withhold LYNOZYFIC based on severity.
Hepatotoxicity: LYNOZYFIC can cause hepatotoxicity. In LINKER-MM1, elevated ALT occurred in 46% of patients, with Grade 3 or 4 ALT elevation occurring in 6%; elevated AST occurred in 61% of patients, with Grade 3 or 4 AST elevation occurring in 10% of patients who received the recommended dose. Grade 3 or 4 total bilirubin elevations occurred in 1.7% of patients. Liver enzyme elevation can occur with or without concurrent CRS.
Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold LYNOZYFIC or consider permanent discontinuation of LYNOZYFIC based on severity.
Embryo-Fetal Toxicity: Based on its mechanism of action, LYNOZYFIC may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LYNOZYFIC and for 3 months after the last dose.
Adverse Reactions
The most common adverse reactions (≥20%) are musculoskeletal pain, cytokine release syndrome, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea. The most common Grade 3 or 4 laboratory abnormalities (≥30%) are decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin, and decreased white blood cell count.
Use in Specific Populations
Lactation: Advise not to breastfeed.
Please see full Prescribing Information, including Boxed WARNING, for LYNOZYFIC.
Reference: LYNOZYFICÔ (linvoseltamab-gcpt) full U.S. prescribing information. Regeneron Pharmaceuticals, Inc.
If you would like to opt-out of messages from Regeneron, you can unsubscribe at any time. To unsubscribe, please respond to this email with the subject line UNSUBSCRIBE.
For Colorado prescribers – Click Here for Pricing Information
For Connecticut prescribers – Click Here for Pricing Information
LYNOZYFIC™ (linvoseltamab-gcpt) is now approved!
LYNOZYFIC is now approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.
This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME
· Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Initiate treatment with LYNOZYFIC step-up dosing to reduce the risk of CRS. Manage CRS, withhold LYNOZYFIC until CRS resolves, and modify the next dose or permanently discontinue based on severity.
· Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS during treatment. Manage neurologic toxicity, including ICANS, withhold LYNOZYFIC until neurologic toxicity, including ICANS resolves, and modify the next dose or permanently discontinue based on severity.
· Because of the risk of CRS and neurologic toxicity, including ICANS, LYNOZYFIC is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LYNOZYFIC REMS.
Please see additional Important Safety Information below.
NDC for LYNOZYFIC
Please ensure that policies and systems are updated to reflect LYNOZYFIC.
LYNOZYFIC dose (mg/mL)
Vial cap color
NDC
5 mg/2.5 mL
White
61755005401
200 mg/10 mL
Blue
61755005601
NDC=National Drug Code.
Note: The product’s NDC has been “zero-filled” to ensure creation of an 11-digit code that meets general billing standards. The zero-fill location is indicated in bold above.
HCPCS Information
Not otherwise classified, antineoplastic
J9999
Unclassified drug
J3490
Unclassified biologic
J3590
Unclassified drug or biologic (limited to ASC or HOPD claims for Medicare beneficiaries)
C9399
ASC=ambulatory surgical center; HCPCS=Healthcare Common Procedure Coding System; HOPD=hospital outpatient department.
Note: When using a temporary miscellaneous J-code, it is appropriate to indicate “1” billing unit on the claim form.
Relevant ICD-10-CM Diagnosis Codes for Relapsed/Refractory Multiple Myeloma (R/R MM)
ICD-10-CM Code
ICD-10-CM Code description
C90.00
Multiple myeloma not having achieved remission
C90.02
Multiple myeloma in relapse
C90.20
Extramedullary plasmacytoma not having achieved remission
C90.22
Extramedullary plasmacytoma in relapse
C90.30
Solitary plasmacytoma not having achieved remission
C90.32
Solitary plasmacytoma in relapse
ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification.
ICD-10-CM Diagnosis Codes for R/R MM After At Least 4 Lines of Therapy
ICD-10-CM Code
ICD-10-CM Code description
Z92.22
Personal history of monoclonal drug therapy
Z92.25
Personal history of immunosuppression therapy
LYNOZYFIC is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called LYNOZYFIC REMS. Visit LYNOZYFICREMS.com to learn more.
LYNOZYFIC Surround™ helps eligible patients access LYNOZYFIC and navigate the insurance process. Enrollment is the first step to accessing support for benefits investigation, prior authorizations, claims, and appeals.
For more information or support, please reach out to your Oncology Reimbursement Manager, call 1.844.RGN.HEME (1.844.746.4363), Option 1, Monday–Friday, 8 am–8 pm Eastern time, or visit LYNOZYFIChcp.com.
This material is provided for informational purposes only, is subject to change, and should not be construed as legal or medical advice. This information may not apply to all patients or to all health plans. Providers should exercise independent clinical judgment when selecting codes and submitting claims to accurately reflect the services and products furnished to the specific patient.
Please contact me if you’d like additional information or if you have questions regarding the attached acquisition guide.
IMPORTANT SAFETY INFORMATION (cont’d)
Warnings and Precautions
Cytokine Release Syndrome (CRS): LYNOZYFIC can cause CRS, which can be serious or life-threatening. In LINKER-MM1, CRS occurred in 46% (54/117) of patients who received LYNOZYFIC at the recommended dose, with Grade 1 CRS occurring in 35% (41/117) of patients, Grade 2 in 10% (12/117), and Grade 3 in 0.9% (1/117). Thirty-eight percent (45/117) of patients had CRS following step-up dose 1, including 1 patient who experienced Grade 3 CRS; 8% (9/117) had an initial CRS event following a subsequent dose. Seventeen percent (19/113) of patients developed CRS after step-up dose 2, 10% (11/111) developed CRS after the first full 200-mg dose of LYNOZYFIC, and 3.6% (4/110) developed CRS after the second full dose. Recurrent CRS occurred in 20% (23/117) of patients. The median time to onset of CRS from the end of infusion was 11 (range: -1 to 184) hours after the most recent dose, with a median duration of 15 (range: 1 to 76) hours.
Clinical signs and symptoms of CRS included, but were not limited to pyrexia, chills, hypoxia, tachycardia, and hypotension. Administer pretreatment medications and initiate therapy according to LYNOZYFIC step-up dosing to reduce the incidence and severity of CRS. Monitor patients for signs and symptoms of CRS after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur.
At the first sign of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines, and administer supportive care; withhold LYNOZYFIC until CRS resolves and modify the next dose or permanently discontinue LYNOZYFIC based on severity.
Infusion Related Reactions
Infusion‑related reactions (IRR) may be clinically indistinguishable from manifestations of CRS. In the patients who were treated with the recommended step-up dosing regimen and pretreatment medications, the rate of IRR was 9% [11/117 including Grade 2 IRR (4.3%) and Grade 3 IRR (1.7%)]. For IRR, interrupt or slow the rate of infusion or permanently discontinue LYNOZYFIC based on severity of reaction.
Neurologic Toxicity, including Immune Effector Cell Associated Neurotoxicity Syndrome: LYNOZYFIC can cause serious or life‑threatening neurologic toxicity, including ICANS. In LINKER-MM1, neurologic toxicity occurred in 54% of patients, with Grade 3 or 4 neurologic toxicity occurring in 8%, at the recommended dose. Neurologic toxicities included ICANS, depressed level of consciousness, encephalopathy, and toxic encephalopathy. ICANS occurred in 8% of patients who received LYNOZYFIC with the recommended dosing regimen, including Grade 3 events in 2.6%. Most patients experienced ICANS following step-up dose 1 (5%). Two patients (1.8%) experienced initial ICANS following step-up dose 2 and one patient developed the first occurrence of ICANS following a subsequent full dose of LYNOZYFIC. Recurrent ICANS occurred in one patient. The median time to onset of ICANS was 1 (range: 1 to 4) day after the most recent dose with a median duration of 2 (range: 1 to 11) days. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.
The most common clinical signs and symptoms of ICANS are confusion, depressed level of consciousness, and lethargy. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient; provide supportive therapy and consider further management per current practice guidelines. Withhold LYNOZYFIC until ICANS resolves and modify the next dose or permanently discontinue LYNOZYFIC based on severity. Counsel patients to seek immediate medical attention should signs or symptoms of neurologic toxicity, including ICANS occur at any time.
Due to the potential for neurologic toxicity, including ICANS, patients receiving LYNOZYFIC are at risk of confusion and depressed consciousness. Advise patients to refrain from driving, or operating heavy or potentially dangerous machinery, for 48 hours after completion of each of the step-up doses and in the event of new onset of any neurological symptoms, until symptoms resolve.
LYNOZYFIC REMS: LYNOZYFIC is available only through a restricted program under a REMS called the LYNOZYFIC REMS because of the risks of CRS and neurologic toxicity, including ICANS.
Infections: LYNOZYFIC can cause serious, life‑threatening, or fatal infections. In patients who received LYNOZYFIC at the recommended dose in LINKER-MM1, serious infections, including opportunistic infections, occurred in 42% of patients, with Grade 3 or 4 infections in 38% and fatal infections in 4%. The most common serious infection reported (≥10%) were pneumonia and sepsis. Two cases of progressive multifocal leukoencephalopathy (PML) occurred in patients receiving LYNOZYFIC.
Monitor patients for signs and symptoms of infection and immunoglobulin levels prior to and during treatment with LYNOZYFIC and treat appropriately. Administer prophylactic antimicrobials, antibiotics, antifungals, antivirals, vaccines, and subcutaneous or intravenous immunoglobulin (IVIG) according to guidelines, including prophylaxis for PJP and herpesviruses. Withhold LYNOZYFIC or consider permanent discontinuation of LYNOZYFIC based on severity of the infection.
Neutropenia: LYNOZYFIC can cause neutropenia and febrile neutropenia. In patients who received LYNOZYFIC at the recommended dose in LINKER-MM1, decreased neutrophil count occurred in 62% of patients with Grade 3 or 4 decreased neutrophil count in 47%. Febrile neutropenia occurred in 8% of patients.
Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local guidelines. Monitor patients with neutropenia for signs of infection. Withhold LYNOZYFIC based on severity.
Hepatotoxicity: LYNOZYFIC can cause hepatotoxicity. In LINKER-MM1, elevated ALT occurred in 46% of patients, with Grade 3 or 4 ALT elevation occurring in 6%; elevated AST occurred in 61% of patients, with Grade 3 or 4 AST elevation occurring in 10% of patients who received the recommended dose. Grade 3 or 4 total bilirubin elevations occurred in 1.7% of patients. Liver enzyme elevation can occur with or without concurrent CRS.
Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold LYNOZYFIC or consider permanent discontinuation of LYNOZYFIC based on severity.
Embryo-Fetal Toxicity: Based on its mechanism of action, LYNOZYFIC may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LYNOZYFIC and for 3 months after the last dose.
Adverse Reactions
The most common adverse reactions (≥20%) are musculoskeletal pain, cytokine release syndrome, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea. The most common Grade 3 or 4 laboratory abnormalities (≥30%) are decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin, and decreased white blood cell count.
Use in Specific Populations
Lactation: Advise not to breastfeed.
Please see full Prescribing Information, including Boxed WARNING, for LYNOZYFIC.
Reference: LYNOZYFICÔ (linvoseltamab-gcpt) full U.S. prescribing information. Regeneron Pharmaceuticals, Inc.
If you would like to opt-out of messages from Regeneron, you can unsubscribe at any time. To unsubscribe, please respond to this email with the subject line UNSUBSCRIBE.
For Colorado prescribers – Click Here for Pricing Information
For Connecticut prescribers – Click Here for Pricing Information
